Quality/GMPs

FDA issued a warning letter to College Pharmacy for multiple violations.

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.

The debate over who has control over patents for CRISPR gene-editing technology came to a head on August 17, 2016 after an email was released from a former graduate student at the Broad Institute accusing Harvard-MIT of wrongfully securing patents to the technology.

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

The Chinese facility was cited for data integrity violations.

Nine public health organizations submitted a letter to members of US House and Senate committees citing concerns with FDA’s decision to make changes to a section of the FDA and NIH Workforce Authorities Modernization Act.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

The company is voluntarily recalling one lot of product due to particulate matter.

The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.

The three-year report emphasizes the roll of collaboration in drug safety.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

Experts discuss recent advances in cell viability testing methods in bioreactors.

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

Multiple methods are required for detecting and removing protein impurities.

Regulators and manufacturers address economic and ethical issues for scarce medicines.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

FDA and industry seek speedy Congressional approval of new user fee plan.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

The company manufactures biological drug products and intermediates for the allergy vaccine market.